Aspirin study will draw on electronic health records

8:49 February 27, 2017

by John Keenan, UNMC public relations

James McClay, M.D.

James Campbell, M.D.

UNMC is participating in a new study comparing the effects of two dosages of aspirin in patients who have a history of vascular disease, and the ADAPTABLE nationwide pragmatic study will be the first at the university to draw extensively from electronic health records.

Interested in participating?

People wishing to participate in the study must be 19 years of age or older, must have a history of vascular diseases (have experienced a heart attack or stroke, had an angioplasty or bypass), and cannot be on any other major coagulants. For information, visit the website, theaspirinstudy.org, or contact Rachel Harper at 402-559-4335.

James Campbell, M.D., and James McClay, M.D., are the principal investigators for UNMC. Dr. McClay is the principal investigator on UNMC’s participation in the National Patient Centered Research Network (PCORnet).”The ADAPTABLE trial is a major demonstration of PCORnet, the national patient centered research network we’ve built over the past three years,” Dr. McClay said. “PCORnet pulls together electronic health record data from over 80 million patients for research studies.”

Working with the Greater Plains Collaborative Research Network, UNMC has been building and enhancing its clinical research data warehouse to make that electronic health record information reusable for clinical research and education.

About the study

The study will compare the effects of two different dosages of aspirin — 325 milligrams, the normal adult aspirin dosage, and 81 milligrams, the amount in a standard baby aspirin — in patients who have known vascular diseases.

“There is good evidence in clinical medicine that aspirin can be beneficial to help to prevent heart attacks and strokes,” Dr. Campbell said. “But it irritates some people’s stomachs and causes them to bleed.”

Historically, there have been studies that have studied everything from 81 to 650 milligrams, and have shown benefits of one type or another, but always with some downside. This study will examine head-to-head effects of the probably minimal effective dose of 81 milligrams and 325 milligrams, the common tablet strength.

“This study is simply trying to verify whether there is a difference in outcomes, complications and also the incidence of heart attack and stroke that differs between those two doses, to try to establish an optimal treatment,” Dr. Campbell said.

The University of Iowa is the lead on the project for the GPC Network.

“The vision for the use and sharing of electronic health records is to improve health care,” Dr. McClay said. “We can transform clinical research through this system.””We’re in the process of networking all of our electronic health records so that physicians can get information in a timely basis, but also so that we can re-use that data — when the patient agrees — for research and public health purposes,” Dr. Campbell said. “So, as a part of the recruitment for this study, we’ve actually pulled up our electronic health record data, and we’ve searched through historical information in order to identify patients that are likely to fit the study criteria.”

In addition to using electronic health records for recruitment of patients through their physicians, investigators — the GPC network, a 13-university collaboration across the Midwest — will be periodically running queries on that data warehouse to look for outcomes in the study.

“If the patient comes in and is hospitalized, and has a heart attack or stroke, we can expect to get that report out of the electronic health record abstract,” Dr. Campbell said. “That will be part of the way of reporting study results. So it is sort of an observational study where the electronic health record is a participant, and we’re networking our electronic health records across the United States. The ADAPTABLE study represents a new way to run comparative effectiveness research.”

“PCORNet and the ADAPTABLE trial, with their use of the electronic health record to answer critically important medical questions, serve as excellent examples of benefits directly related to the integration of UNMC and Nebraska Medicine,” said Chris Kratochvil, M.D., associate vice chancellor for clinical research, UNMC, and vice president for research, Nebraska Medicine.

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